Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2023
• Main ID: NCT04079088
• Date of registration: 03/09/2019
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
• Scientific title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis
• Date of first enrolment: June 30, 2021
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04079088
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Diagnosed with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive
multiple sclerosis (SPMS)

- Have a Baseline Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0

- Have a MS disease duration of =20 years from first MS symptom(s)

- Must have at least one of the following occurring within 12 months prior to

Day 1/Baseline:

(a) =1 clinical relapse(s) or objective disability worsening (as per treating neurologist's
judgment) (b) =1 Gadolinium (Gd)-enhancing T1 lesion(s) on brain or spinal cord Magnetic
Resonance Imaging (MRI) (c) =1 new T2 lesion(s) on brain or spinal cord MRI (the reference
scan used to detect new T2 lesion formation has to be =12 months prior to Day 1/Baseline)

- Must have been taking one of the following disease-modifying therapy (DMTs) at a
stable dose for at least 12 weeks prior to Day 1/Baseline:

1. Interferon-beta1 (IFN-ß1): Avonex, Plegridy, Betaferon/Betaseron, Extavia, or
Rebif

2. Glatiramer acetate (Copaxone or Glatopa).

Key Exclusion Criteria:

- A documented history of clinically significant persistent neutralizing antibody
against IFN-ß1 (applicable only for participants entering the study with IFN-ß1 as a
background DMT), in the opinion of the Investigator

- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to Gd, renal impairment, or
claustrophobia that cannot be medically managed

- History or a positive test result at Screening for human immunodeficiency virus

- Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody
and detectable HCV Ribonucleic acid (RNA)). Participants with positive HCV antibody
and undetectable HCV RNA are eligible to participate in the study (United States [US]
Centers for Disease Control and Prevention)

- Current hepatitis B infection (defined as positive for hepatitis B surface antigen
[HBsAg] or total hepatitis B core antibody [anti-HBc]). Participants with immunity to
hepatitis B from previous natural infection (defined as negative HBsAg, positive
anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination
(defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to
participate in the study

- History of systemic hypersensitivity reaction to BIIB061

- History of suicidal ideation or an episode of clinically severe depression (as
determined by the Investigator) within 12 weeks of screening

- Clinically significant (as determined by the Investigator) 12-lead ECG or laboratory
assessment abnormalities

- Any condition affecting study treatment absorption (e.g., gastrectomy)

- Treatment with statins (3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors)
or proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors (e.g., alirocumab and
evolocumab) within 8 weeks prior to Day 1/Baseline

- Inability or unwillingness to comply with study requirements

- Other unspecified reasons that, in the opinion of the Investigator or Biogen that make
the participant unsuitable for enrollment.

Note: Other protocol defined inclusion/ exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Glatiramer acetate

Biological: Interferon-beta1

Drug: Placebo

Drug: BIIB061

Primary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: First dose of study drug to end of the study (Up to Week 84)]

Overall Disability Response Score (ODRS) at Week 48 [Time Frame: Baseline, Week 48]

Secondary Outcome(s)

Change from Baseline in Normalized T1 (nT1) Intensity at Week 48 [Time Frame: Baseline, Week 48]

ODRS using 20% Threshold for T25FW over the First 48 Weeks of Treatment [Time Frame: 48 weeks]

ODRS Accounting Only for 12-week Confirmed Events of Worsening and Improvement on Respective Components over the First 48 Weeks of Treatment [Time Frame: 48 weeks]

Change from Baseline in Normalized Magnetization Transfer Ratio (nMTR) at Week 48 [Time Frame: Baseline, Week 48]

ODRS using 20% Threshold for T25FW, 9HPTD, and 9HPT-ND over the First 48 Weeks of Treatment [Time Frame: 48 weeks]

Percentage of Participants with 12-week Confirmed Worsening in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND [Time Frame: Up to Week 48]

Change from Baseline in Diffusion Tensor Imaging Radial Diffusivity (DTI-RD) at Week 48 [Time Frame: Baseline, Week 48]

Percentage of Participants with 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND [Time Frame: Up to Week 48]

Change from Baseline in T1 Hypointense Volume at Week 48 [Time Frame: Baseline, Week 48]

Secondary ID(s)

2019-001847-28

231MS201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors